Process optimization, characterization and pharmacokinetic evaluation in rats of ursodeoxycholic acid-phospholipid complex

AAPS PharmSciTech. 2008;9(1):322-9. doi: 10.1208/s12249-008-9040-1. Epub 2008 Feb 7.

Abstract

The purpose of this research was to study whether the bioavailability of ursodeoxycholic acid could be improved by administering ursodeoxycholic acid-phospholipid complex (UDCA-PLC) orally to rats. A central composite design approach was used for process optimization in order to obtain the acceptable UDCA-PLC. The physicochemical properties of the complex obtained by optimal parameters were investigated by means of scanning electron microscopy and X-ray diffraction. The pharmacokinetic parameters and bioavailability studies were conducted in rats of UDCA after oral administration of UDCA-PLC and UDCA tablet. Multiple linear regression analysis for process optimization revealed that the acceptable UDCA-PLC was obtained wherein the optimal values of X(1), X(2) and X(3) were 3, 60 degrees C and 3 h, respectively. The XRD studies of UDCA-PLC obtained by the optimal parameters demonstrated that UDCA and phospholipids in the UDCA-PLC were combined by non-covalent bonds, not form new compounds. But pharmacokinetic parameters of the complex in rats were T(max) 1.6 h, C(max) 0.1346 microg/ml, AUC(0-infinity) 11.437 microg x h/ml, respectively. The relative bioavailability of UDCA of UDCA-PLC was increased by 241%,compared with the reference ursodeoxycholic acid tablet.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Biological Availability
  • Diffusion
  • Drug Carriers / chemistry
  • Drug Compounding / methods*
  • Drug Evaluation, Preclinical / methods
  • Male
  • Organ Specificity
  • Phospholipids / chemistry*
  • Rats
  • Rats, Wistar
  • Tissue Distribution
  • Ursodeoxycholic Acid / administration & dosage
  • Ursodeoxycholic Acid / chemistry*
  • Ursodeoxycholic Acid / pharmacokinetics*

Substances

  • Drug Carriers
  • Phospholipids
  • Ursodeoxycholic Acid